Hormone Pregnancy Tests

Yasmin Qureshi Excerpts

Tuesday 23rd April 2019 Westminster Hall

[Yasmin Qureshi (Bolton South East) (Lab)]

I beg to move,

That this House has considered the Expert Working Group report on hormone pregnancy tests.

It is a pleasure to serve under your chairmanship, Mr Hollobone. I am also pleased that the Under-Secretary of State for Health and Social Care, the hon. Member for Thurrock (Jackie Doyle-Price), is here to respond to this debate.

To establish the context of the debate, I will begin by acknowledging the extraordinary hard work and determination of Marie Lyon, who is here with us in Westminster Hall today. She has led the campaign on behalf of the victims of hormone pregnancy tests, and alongside her husband has travelled the length and breadth of this country, and even been to Germany, to support victims.

It has been my pleasure to work with Marie since the beginning of this campaign, alongside others including Jason Farrell, who has pursued this story for Sky News from the start; Professor Neil Vargesson of Aberdeen University; and Professor Carl Heneghan and Dr Jeffrey Aronson, both of Oxford University, whose recent work is the basis of this debate.

By way of providing more background, I remind the House that Primodos, the hormone pregnancy test drug, was taken by approximately 1.5 million women in the 1960s and 1970s to test for pregnancy. The dosage contained in those Primodos tablets was 40 times the strength of an oral contraceptive that would be prescribed today. There is considerable evidence that many women who took this drug either gave birth to babies with serious deformities, or miscarried, or had stillbirths. Those babies are now in their 40s and 50s, and they have had to live a lifetime with serious disabilities.

To this day, not one Minister or one review has been able to answer some very simple questions. First, why were no official warnings issued about this drug until eight years after the first major report that indicated possible dangers? Why were some doctors still prescribing this drug for pregnant women after official warnings were issued by the Committee on Safety of Medicines? And why were some GPs able to pull out Primodos tablets from their desk drawers and hand them to women?

I secured this debate to seek answers in respect of the Medicines and Healthcare Products Regulatory Agency-led expert working group. That was the scientific review set up on the instruction of a former Minister, the hon. Member for Mid Norfolk (George Freeman), following my Backbench Business Debate on this issue in 2015. He had clearly stated to us that this review would “thoroughly” consider all the evidence.

Such is the depth of concern about this issue that there have already been three debates on the expert working group’s review—this is the fourth. Each and every time, Members from across the House have urged Ministers to consider our concerns about the methodology, the independence of the panel members and the conclusions of the report. On each and every occasion, however, our concerns have been dismissed.

[Gordon Marsden (Blackpool South) (Lab)]

I congratulate my hon. Friend on securing this debate and on the absolutely focused way in which she has conducted this campaign, with other Members here today and with Marie Lyon. I also pay tribute to the hon. Member for Mid Norfolk (George Freeman), the former Minister: it is not easy for Ministers to override the advice of their civil servants, but he did on that occasion. That, however, makes it all the more concerning that, on 24 October last year, Lord O’Shaughnessy wrote my hon. Friend a letter that was rather confusing and defensive, and did not make any reference to enforcing a rethink by the MHRA.

We know that there are issues about how the meta tests are done, and I am sure that my hon. Friend will come on to that. However, at this stage does she still find it very concerning that Ministers have not grasped the nettle?

[Yasmin Qureshi]

I thank my hon. Friend for that intervention and I absolutely agree with him; he can probably hear in my voice some of my frustration about the fact that this issue has not been grasped by Ministers and dealt with.

In recent months, the all-party parliamentary group on hormone pregnancy tests, of which I am the chair, has written to Ministers several times to ask for meetings so that we can discuss these concerns, but each time our request has been declined. Perhaps the Minister here today could shed some light on what exactly the Government are so intent on hiding each time they refuse the request by a group of MPs for a meeting.

Let us not forget that the review was cloaked in secrecy from the very start. As an observer, Marie Lyon was forced to sign a “gagging clause”, which, if breached, could have resulted in a prison sentence. Families who gave evidence to the panel reported being treated appallingly by the MHRA. Despite the MHRA’s insistence that the expert working group was independent, two panel members had to be removed after Marie Lyon discovered conflicts of interest.

Perhaps the most shocking fact was that this review was set up with terms of reference that stated very clearly that it would seek to find a “possible association”, but the review panel and the Commission on Human Medicines chose to ignore that and instead concluded that a

“causal association could not be found between the drug and birth defects.”

Each time that Ministers have been questioned about this review, we have been told that it was

“robust, comprehensive, independent and scientific”.

If that really is the case, I hope that the Minister can provide us with answers today as to why we now have evidence, which I will set out, that clearly proves that the expert working group review was anything but robust and comprehensive.

Last November, a team of experts led by Carl Heneghan, the Professor of Evidence-Based Medicine at Oxford University, conducted a systematic review of all previous human studies. They discovered that when the data is pooled properly it shows “a clear association” with several different forms of malformation. The results were clear that there is an association that is significant. That tells us that the expert working group’s review completely failed to adopt the right approach for a systematic review. Why did it not pool all the data together and properly collate it to show an overall effect? I should also point out that Professor Heneghan’s study has been published in a peer review journal, whereas the expert working group’s review was not even scrutinised.

However, Professor Heneghan did not stop there. Marie Lyon obtained raw data used by the expert working group via a freedom of information request. It is worth noting that despite the MHRA’s claim of “transparency”, this data was not already in the public domain. The cynical among us might ask: why was that? Why hide it?

That raw data was then assessed by Professor Heneghan and his team, who carried out a meta-analysis on it, and again they found that there is an association between the drug and birth defects. Let me just repeat that point again—raw data used by the MHRA for the expert working group review was assessed by independent experts at Oxford University and it was found that Primodos causes deformities.

Can the Minister appreciate why that has led to suspicion that key elements of the research were removed from the report in order for the expert working group to reach its conclusion, and why campaigners feel that Ministers and Parliament may have been misled, given that it appears that key information was being withheld from the report in order to suggest that there is no link between Primodos and deformities?

[Gordon Marsden]

My hon. Friend is being gracious in allowing interventions. Does she not consider it confusing that the group, and indeed the MHRA, seem to be reluctant regarding meta-analysis, when only recently the National Institute for Health and Care Excellence used it to reinstate surgical mesh in the treatment of prolapse? It is widely understood to be a common method—the US Food and Drug Administration and the European Medicines Agency have adopted it. Why are we lagging behind? Perhaps the Minister would like to comment on that in her reply.

[Yasmin Qureshi]

My hon. Friend is absolutely right and I come on to explain how other bodies use meta-analysis to carry out assessment.

Does the Minister understand why we are asking why the data was not even properly assessed? When I tabled a parliamentary question to inquire whether the meta-analysis of the studies had been carried out, I was told that it had not. Can the Minister explain why not? One of the experts on the panel, Professor Stephen Evans, recently made a poor defence of meta-analysis not being used in the review, by relying heavily on a paper called, “Meta-analysis. Schemata analysis”, which was published 25 years ago. The expert working group seems not to have considered meta-analysis an appropriate way in which to assess the data. Why not? Why did it refuse to take an evidence-based approach?

Neither the Minister nor I is a scientist, but she is aware that meta-analysis is the statistical procedure that combines data from multiple studies. When treatment effect is consistent from one study to the next, as with Primodos, it is completely appropriate and evidence-based to use a meta-analysis to assess the data. Pharmaceutical companies use it to approve new drugs. The US Food and Drug Administration uses it. The European Medicines Agency uses it for the approval of drugs, and clinicians and researchers in medicine, education and the criminal justice system use it to determine whether a treatment works. The National Institute for Health and Care Excellence uses meta-analysis, and it is the cornerstone of Cochrane—previously known as the Cochrane Collaboration. The only group that discounts meta-analysis is the MHRA. Why? To say that meta-analysis was not the appropriate method is completely incompatible with an evidence-based approach.

Let me take up the matter of the independence of the expert working group. We have been told several times, by a number of Ministers, that the entire process was completely independent. It is my view that the Government are not well served by their current processes, the lack of independence and the lack of impartiality. What is in doubt is the question of whether the Government have the independent expertise required to hold Government bodies such as the MHRA to account and provide us with independent evidence with which to make informed decisions.

As the Minister is aware, in February 2018, Baroness Cumberlege began a joint non-scientific review into Primodos, sodium valproate and mesh implants, and we expect it to conclude in the next few months. Baroness Cumberlege invited the expert working group to give oral evidence to the review team, and this is how Ailsa Gebbie, the group’s chair, described herself at the beginning of an evidence session:

“I’m also the chair of the MHRA and the expert working group on hormones and women’s health that reviews all products and medicines and drugs related to women”.

What does independent mean if the chair describes herself in that way?

In 2015, the Commission on Human Medicines agreed to establish an expert working group to review the available data on a possible association between the hormone pregnancy test, Primodos, and adverse outcomes in pregnancy, and to make a recommendation. The commission appears to have commissioned the MHRA to do an independent review. Perhaps the independence of the MHRA can be summed up in its response to Marie Lyon, who in conversation with the agency had reminded it of its responsibility to the public interest. She was immediately corrected:

“No, the job of the MHRA is to represent Pharma”.

Of course, the agency is correct—it is substantially funded by the pharmaceutical industry and cannot be considered independent by any stretch of the imagination. Can the Minister explain why we are expected to have confidence in the independence of a review that was run by an organisation part-funded by pharma? How can we be expected to trust claims that Bayer, the manufacturer of Primodos, has no links to the MHRA? Yes, we had a review, but I am not sure we can call it independent. Will the Minister do the right thing and withdraw the expert working group report?

If the Minister needs any further evidence, perhaps I can point her to the testimony of Sandra Malcolm, a recent whistleblower. Mrs Malcolm worked for the manufacturer of Primodos, which is now owned by Bayer. While at the company in 1971, she discovered she was pregnant and spoke to colleagues:

“I was in reception one day and there were two guys there. One may have been a medical rep and he said to me ‘you want a dose of Primodos’ and the other said ‘I think it’s been taken off the market’, and the other one said ‘no, you can get it’. So with that information I went upstairs to see one of the doctors. I said ‘I’m a week overdue and can I have some Primodos?’ And he said ‘I can’t give it to you because it may not work and it may cause deformities’, so I thought that was a definite no.”

Mrs Malcolm said that after the conversation she decided not to take the drug “for obvious reasons” and that she assumed it was no longer on the market. However, many years later, when she saw a report about Primodos causing deformities, she was shocked to discover it had remained on the market for many years after problems had been listed.

Vast swathes of evidence clearly point to a cover-up by the drug company and the Government regulators at the time. It is utterly disgraceful that until this day the evidence has been ignored, as it was by the expert working group review.

[Mr George Howarth (Knowsley) (Lab)]

I am grateful to my hon. Friend, not just for securing the debate and for the way in which she has conducted it, but for her leadership on the issue over a long period. One of the more modern—I say modern; I think it was in the 19th century —versions of the Hippocratic oath is the principle, “Do no harm”. Does she agree—and she has made a powerful case for this—that as harm has been done we should acknowledge the consequences and deal with them appropriately?

[Yasmin Qureshi]

I thank my right hon. Friend for that intervention, and I absolutely agree with him. He may have realised what the ending of my speech was going to be, because that was a point I was going to make.

Not once did the expert working group mention the historical evidence in its review; not once did it look at those documents and acknowledge that there are questions to be answered. Primodos has been the cause of devastating effects, and much of the current suffering is the result of ongoing uncertainty. We must accept that we cannot achieve certainty in all things, but we can admit our failings. Victims of Primodos need an acknowledgement of liability, and it is time that we gave them an apology. When will the Government stop wasting time and public money by setting up these so-called independent ad hoc expert working groups each time scientific evidence clearly shows that the use of Primodos caused birth defects, just so they can dismiss the evidence and continue to cover up what one lawyer has called the biggest medical and legal cover-up of the 20th century?

On behalf of my four constituents and their families, and on behalf of thousands of families across the country and over 130 members of the all-party parliamentary group on hormone pregnancy tests, I urge the Minister to listen to these concerns, as well as those of other Members present. I urge her to be brave, and to have the courage to say “Enough is enough.” From today, let us stop putting our heads in the sand. Let us look at the evidence that Professor Heneghan has presented, and give Primodos victims the justice they deserve.

--- Later in debate ---

[Yasmin Qureshi]

I thank the hon. Members for Ayr, Carrick and Cumnock (Bill Grant), for Argyll and Bute (Brendan O'Hara) and for Livingston (Hannah Bardell), my hon. Friends the Members for Wolverhampton North East (Emma Reynolds) and for Makerfield (Yvonne Fovargue), and the right hon. Members for Hemel Hempstead (Sir Mike Penning) and for Kingston and Surbiton (Sir Edward Davey). I thank my hon. Friend the Member for Blackpool South (Gordon Marsden) for his helpful interventions.

I am very disappointed with the response the Minister has given. The questions and interventions that my colleagues have voiced suggest their disappointment as well. She has said what all the Ministers have been saying, which is basically reading out the civil service line—Sir Humphrey-speak. We have raised a number of serious questions. We raised the constitution of the expert working group—the people who sat on the panel. In meetings I had with the then Minister—the right hon. Member for North Norfolk (Norman Lamb)—and civil servants, we sat and discussed what they would to be looking at. They assured us that all the documents and available evidence would be looked at. Clearly, some of it has not been looked at, yet there is no promise to look at all the evidence in this case.

The scientific studies by Professor Vargesson have been mentioned. As the right hon. Member for Hemel Hempstead said, the human body shares about 70% of the genetic code of the zebrafish. They were found to be damaged. Most of us listening to the Minister are just gobsmacked by what we are being told. None of the issues that have been raised today has really been taken on board.

Motion lapsed (Standing Order No. 10(6)).

Social Care

Yasmin Qureshi Excerpts

Wednesday 25th April 2018 Commons Chamber

[Barbara Keeley]

It tends to be outstanding in the independent sector. Charities in particular can be outstanding, although they are not always so.

The care sector’s funding crisis also has an impact on the growing number of people who need care but are given none at all. More than 1.2 million people are now living with unmet care needs, many of them isolated and lonely, and that number rises to 1.5 million with the addition of people who need assistance with taking medication. Unmet needs can lead to people being forced to wear incontinence pads overnight because there is no one to help them to get to the toilet, which takes away their dignity. The number of older people living with unmet care needs will inevitably rise without an injection of new funding, because of the growing demand for care in our ageing population.

It is clear that the social care system needs sustainable funding from central Government, but the Government’s response to the crisis so far has been to push the funding problem on to hard-pressed councils and council tax payers through the social care levy. The only increase in Government funding has been the paltry £150 million extra for social care in the local government finance settlement. That is nowhere near enough to avert the crisis that the Government have created in social care. Moreover, it was not the new money that councils desperately needed. The Government admitted that the increase would be funded through an expected underspend in existing departmental budgets.

It is clear that local authorities are now facing some of their greatest challenges just to make ends meet. I want to highlight the heroic efforts of Labour councils to protect adult social care in the face of swingeing budget cuts from the Government.

[Yasmin Qureshi (Bolton South East) (Lab)]

My hon. Friend has referred to Labour councils. In each of the last two years, my local authority, Bolton Council, has had to increase its council tax rates by 3% and 2% respectively in order to fund social care, and it will have to increase them next year as well. It has had a shortfall of £6 million, and has been able to cover it only by increasing council tax, which is really not acceptable.

[Barbara Keeley]

Indeed. As I have said, the Government have pushed the problem on to councils, which have been forced to use their reserves, and pushed the council on to council tax payers, who have had to pay the levy.

I was talking about the heroic efforts of some councils. Despite budget cuts, which are now running at between 40% and 50%, my local authority, Salford City Council, and neighbouring Manchester City Council have acted to ensure that care providers with which they contract will pay care staff a real living wage, and I know that Labour councils in Lambeth, Southwark and many other London boroughs have committed themselves to paying their care staff the London living wage.

--- Later in debate ---

[Caroline Dinenage]

If hon. Members will bear with me, I will now make some progress.

The tough spending choices that we have made have paid dividends, meaning that we have turned a corner in recent years. That is why local government will be able to increase spending on adult social care in real terms in each of the next three years. Our population is growing, ageing and diversifying. At the same time, the money, means and methods that we deploy to serve their long-term health and care needs are under increasing pressure to deliver, and we need to address those issues now.

There is recognition across the House that even if we had an infinite amount of money to fix the problem, the system would need reform. We are taking steps to make the system more effective and to ensure that it better serves the needs of vulnerable people and society in general. That is why this summer’s Green Paper will complement those measures and ensure that our social care system is placed on a sustainable footing and will serve this nation for generations to come.

The Secretary of State recently outlined the seven key principles guiding our thinking on social care as we approach the Green Paper: quality, whole-person integrated care; control; workforce; supporting families and carers; a sustainable funding model for social care; and security for all. As I have said, this is not just about older people. The Green Paper will cover a range of issues that are common to all adults with care and support needs, but we are committed ensuring that any issues relating to social care that are specific to adults of working age are identified and given the right focus. Work on that is being led jointly by the Department of Health and Social Care and the Ministry of Housing, Communities and Local Government.

I will reflect on some of the Green Paper’s themes, but first I will highlight a couple of areas where real progress has been made. I have said that we know there is growing pressure on local authorities’ finances, but it simply is not true that this Government are failing to deal with or acknowledge the crisis.

[Yasmin Qureshi]

The Minister talks about trying to use finances appropriately. My local council has had a 54% cut to the funding that it receives from central Government, which is why it has a shortfall in funding for social care.

The Government have been able to find money to cut corporation tax, capital gains tax and inheritance tax, as well as £1 billion for the Democratic Unionist party. Are they really saying this is all about austerity and choices? Is it not really that the Government have different priorities from the Opposition?

[Caroline Dinenage]

I can honestly say with my hand on my heart that the Labour party does not have a monopoly on care or kindness.

I mentioned earlier that local authorities will receive a real-terms, above-inflation increase in their funding profile. We have announced significant dedicated funding for social care. The Opposition regularly seem to forget that we allocated an additional £2 billion to social care only a year ago, with a further £150 million this year. That means councils have access to £9.4 billion of dedicated funding.

Medicines and Medical Devices Safety Review

Yasmin Qureshi Excerpts

Wednesday 21st February 2018 Commons Chamber

[Mr Hunt]

My hon. Friend’s question demonstrates how useful it is to have people with medical experience in the House. To be honest, I am slightly overwhelmed by the detail in her question, but her broad point is absolutely right. The difficulty with the issues today is how much they affect women, particularly pregnant women. Through the review, we want to establish whether we are doing less well than we should on women’s health issues. Given that Baroness Cumberlege has done more campaigning on women’s health issues than pretty much anyone else in either House, I think she is the right person to take the review forward. My hon. Friend is absolutely right about strengthening the protections for pregnant women.

[Yasmin Qureshi (Bolton South East) (Lab)]

As the chair of the all-party group on oral hormone pregnancy tests, I am disappointed with the wording of today’s announcement. What happened with Primodos was a scandal similar to the Hillsborough, contaminated blood and sexual abuse scandals. Victims of Primodos and their families have waited 40 years for an answer to this grave historical injustice. It was a deliberate criminal cover-up by the statutory authorities of the day. The scientific evidence now shows a link between Primodos and deformities that was known to the drugs companies and our regulatory bodies 40 years ago. Will the Secretary of State ensure that the review—we want a full public inquiry—looks at the regulatory failures that took place 40 years ago? There was a systematic and deliberate cover-up, including the destruction of documents, by our health bodies as well as the drugs manufacturers. Primodos is, therefore, perhaps different from some of the other cases. We demand a proper inquiry and proper compensation and that the victims be put at the heart of the inquiry. They were completely ignored by the expert working group—that document was not worth the paper it was published on.

[Mr Hunt]

The hon. Lady and I may not agree on every part of my statement, but I thank her for her campaigning on this issue, and for the voice that she has given to thousands of women who believe that they have suffered badly as a result of Primodos. The things for which she has asked were not ruled out in the statement; in fact, what I have announced will create a process during which someone will look very carefully at the issue.

The hon. Lady has made some very serious allegations, and it is absolutely her right to do so as a Member of this House, but they differ from the conclusions reached by the expert working group. It is precisely because of that disagreement that we have asked Baroness Cumberlege to look carefully at the issue and form her own view of the right way forward. However, I assure the hon. Lady that regulatory failures are at the front of our minds, and we are absolutely determined to ensure that victims’ voices are heard.

NHS Winter Crisis

Yasmin Qureshi Excerpts

Wednesday 10th January 2018 Commons Chamber

[The Secretary of State for Health and Social Care (Mr Jeremy Hunt)]

I, too, start by offering, on behalf of the whole House, a massive “thank you” to all staff across the health and care system who went beyond the call of duty and gave up their Christmas and new year to keep patients safe. Their dedication makes the NHS the best healthcare system in the world. They visibly demonstrated their values, constantly putting the needs of patients before their own.

Attempts to politicise pressures on the NHS are a serious mistake. The last time the NHS had a difficult flu winter was 2009—the hon. Member for Leicester South (Jonathan Ashworth) might know that, because he was working in Downing Street at the time. In 2009, the shadow Health Secretary was Andrew Lansley. He refused to attack the Government, because it was an operational issue—in fact, the then Health Secretary, Andy Burnham, thanked him for his “measured tone”, which meant that

“together we can give a reassuring message to the public”.—[Official Report, 12 June 2009; Vol. 493, c. 1056.]

Sadly, I cannot say that to the shadow Health Secretary today.

The hon. Gentleman, who has used some extraordinary language today, says that the NHS is on its knees. Let us look at the facts: since 2010, we have 14,000 more doctors, 12,000 more nurses on our wards and 5,000 more operations every single day; and in A&Es, which he talked about a lot, 1,800 more people are seen and treated within four hours every single day.

[Yasmin Qureshi (Bolton South East) (Lab)]

In the spirit of sounding conciliatory, I thank the right hon. Gentleman for giving way. The Royal Bolton Hospital made provision for the Christmas period, but despite that it has had to cancel all routine operations, as well as elective operations in trauma and orthopaedics, until 1 February. What financial assistance will he give my local hospital, so that it does not suffer as a result?

[Mr Hunt]

We did provide an extra £1.4 million to the hon. Lady’s local hospital before Christmas, to help it to deal with the immediate pressures, but let me deal with this issue of cancelled elective care operations. I agree with the shadow Health Secretary that it is a big deal for patients who are told that their planned procedure is to be postponed. No one minimises the distress that that causes, but last year and in previous winters operations were cancelled at the last moment, which is much more distressing and challenging for hospitals to plan around. The decision was taken this year to take a much more planned approach. We hope that, overall, fewer operations will be cancelled at the last moment, but we need to do this in a planned way.

Hormone Pregnancy Tests

Yasmin Qureshi Excerpts

Thursday 14th December 2017 Commons Chamber

[Yasmin Qureshi (Bolton South East) (Lab)]

Six years ago, I met my constituent Nichola Williams, who shared with me her struggle with her health over her lifetime. Her mother had been prescribed Primodos. From there, I carried out my research, searching for answers and going through thousands and thousands of pages of documents.

One document was a 1969 study by a Dr Norman Dean, who worked with the Royal College of General Practitioners. He found that when women used this hormone pregnancy test, there was a higher incidence of malformed babies, miscarriages, stillbirths and infant deaths. He found the findings so alarming that he wrote to the manufacturers advising them that Primodos should be withdrawn. However, it took another eight years for it to be finally taken off the market, unlike in Norway and Sweden, which apparently acted very swiftly.

In the last six years, I have exchanged countless letters with Ministers and Department of Health officials, working alongside Jason Farrell from Sky News, who has dedicated an enormous amount of time to exposing this issue, and Marie Lyon, the chair of the victims association, who has tirelessly campaigned for justice. I have raised this matter on the Floor of the House many times. I raised it with the Prime Minister several weeks ago, and I also met her predecessor to discuss it.

In 2014, after a debate in this Chamber, we were informed by the then Minister that an inquiry would be carried out, and we were very excited about that. We were promised that the inquiry would be fair, open and transparent, would have the trust and confidence of all the victims and would look at all evidence. Instead, we found that some experts on the panel had conflicts of interest and close ties with the manufacturer, which is now Bayer.

The victims who were invited to give evidence were treated appallingly and were given a very short period—I think it was two hours—to explain what had happened to them. Ms Lyon, who had been appointed as an observer to the panel, was forced to sign a gagging clause, which meant she could not raise with us any of the concerns she had about how the inquiry was going.

[Mims Davies]

I thank the hon. Lady for mentioning the interest our Prime Minister has shown. She met Conservative Members recently, and she is watching with interest. However, the issue I would like to reiterate on behalf of my constituents and many other MPs is the treatment of the campaigners during this process. We had unacceptable timescales, and some of these people were caring for very ill children. The treatment of the campaigners, at the very least, needs some kind of apology.

[Yasmin Qureshi]

I entirely agree with the hon. Lady on this matter.

The inquiry was intended to look at a possible association, not a causal link. That is very important because a different burden of proof is required for a possible association as opposed to a causal link. That was changed, and nobody can tell us who gave the authorisation to do that. The EWG was asked to look at regulatory failures. There are thousands of documents from archives in Berlin and Kew that show that there was a link between the deformities and these drugs. The Committee on Safety of Medicines looked at these documents and decided not to do anything with them. Why was that? When the report came out, the initial draft said that it was impossible to reach a definitive conclusion. However, the final document was changed to say that it could reach that conclusion. When the chair of the inquiry was asked why this happened—by Jason Farrell, by me and by other colleagues in a recent discussion—she said that the Commission on Human Medicines looked at the documents very thoroughly and told the panel that

“we should strengthen the wording and put a greater clarity on it.”

It is unacceptable for the commission to have asked the panel to change its conclusion.

When I raised the report with the Prime Minister recently, one of the reasons she said that there was confidence in it was that Nick Dobrik had said that he endorsed it. However, he has said:

“I was very angry when I was informed that my name was used to endorse the conclusions of this report.”

Is the Minister aware that the EWG refused to look at the most up-to-date study on Primodos conducted this year by Dr Neil Vergesson? It said that the study had not been peer-reviewed, yet it looked at 44 other non-peer-reviewed studies, some of which had been produced by the manufacturer itself, Schering. Dr Vergesson found that Primodos deformed fish embryos, and if given in high doses actually killed them. Dr Dean apparently carried out a study and wrote to Schering telling it what his findings were. He also informed the Royal College of General Practitioners about this. That study has also been ignored, and there is no record of it at all. We know that it exists only because a letter was found showing that he had discussed this matter and told all the parties concerned what was going on, but again nothing happened.

The man in charge of the Committee on Safety of Medicines—its chief scientist, Dr Inman—also conducted a study and found that there was an adverse reaction. Instead of dealing with the issue, he contacted the manufacturer and told them to

“take measures to avoid medico-legal challenges.”

Documents from Berlin show that he later said that the documents on which he based his investigation were going to be destroyed. He made that admission at a meeting with a Schering scientist in Bermuda. A Dr Greenberg carried out a study that showed a significant twofold increase in risk of malformed babies being born to women who took this drug. Eventually, in 1977, the Committee on Safety of Medicines wrote to doctors saying that the drug should stop being given. It said that “the association is confirmed” between Primodos and deformities. It was “confirmed”, unequivocally—and that was in 1977.

Why does the EWG seem to have disregarded all these studies, not to have bothered to take any interest in what was happening and failed to look at the regulatory failures? It is vital that further scientific research is carried out not only to establish an association, but because the EWG report says that the component parts of Primodos are currently safe to be used. That is very worrying, because it is being used in many contraceptive pills. Studies and independent research should be carried out on this, because we might find that even though the drug is being used, it might be harmful to women, and we could prevent further problems from occurring. I am asking for an independent inquiry into the regulatory failures. We must put the families first.

--- Later in debate ---

[Peter Heaton-Jones (North Devon) (Con)]

I congratulate my right hon. Friend the Member for Hemel Hempstead (Sir Mike Penning) on securing this debate under the auspices of the Backbench Business Committee. This was one of the very first issues brought to me by a constituent following my election as the Member for North Devon two and a half years ago, and I want to raise her case again.

The people affected—the families, children, mothers and babies—should be at the very centre of our thinking. I will give one example. I was contacted by my constituent Diane Surmon from Barnstaple. She gave birth to her daughter Helen Jean Marie Barham on 29 November 1974. Diane wrote to me to say that she was given Primodos on 10 April that year, while she was pregnant—she remembers the date all too clearly. She was given the hormone pregnancy test. She was living in Cwmbran at the time and Helen was eventually born in the Royal Gwent Hospital in Newport. However, the baby was born with a number of conditions: Helen had hydrocephalus—a very rare disease—and suffered a brain haemorrhage at 12 weeks of age. Her seizures then started; she was treated at the Heath Hospital in Cardiff and then at a later date at Great Ormond Street Hospital. Diane has a letter from a consultant neurologist at the time, which states that in his opinion the drug Primodos had caused the difficulties to her baby.

Diane told me that Helen does have a quality of life. She can walk, albeit short distances. She needs a wheelchair for longer distances, or when she goes shopping or goes out with friends for a meal, for instance. She is able to feed herself, but help with her daily needs is required and she will always need 24-hour care because of her seizures.

That is one example of the extraordinary impact this has had on one family and one individual and one mother, but that can be multiplied so many times, and that is why it is absolutely right that my right hon. Friend the Member for Hemel Hempstead and others on both sides of the House—this is not a party political issue—seek to ensure this issue is kept in the spotlight. It is right that it is.

Therefore, there are many others in situations like that of Mrs Surmon. Over the years, there have been many attempts by Governments of all colours to get to the bottom of this. I know the Minister is sincere in trying to do that and to find a way forward that will help us get to the bottom of what has happened. There has also been a whole range of studies over the years. The difficulty is—this is the nub of the point I want to get across—that there is so much contradiction between all those studies; there is no agreement yet. The hon. Member for Bolton South East (Yasmin Qureshi) delivered a good speech and rightly made the point that in the 1970s there was a report that showed, apparently clearly, evidence of a causal link. However, in 2016, the report from the Commission on Human Medicines said that there was no such evidence. Now we have had this report from the expert working group, which has come up with a similar finding. As we have so many contradictions and differences of opinion, how do we get to the bottom of this?

[Yasmin Qureshi]

The report by the Commission on Human Medicines was a result of a letter I wrote to the Medicines and Healthcare Products Regulatory Agency. The report was not a study into the drug itself; the commission just looked at documents that were in existence, conducted a review on the basis of those documents and gave an opinion. It was not a study.

[Peter Heaton-Jones]

I thank the hon. Lady for that clarification. Many of these studies have been into the historical evidence and the paperwork, which have been sifted through over and again—she is right to make that point—but there are still differences of opinion between what was said in the 1970s, in 2016 and in 2017, and that is the difficulty.

I have asked the House of Commons Library for quite a lot of background information, which I was going to try to get into, but in the six minutes allowed to me I cannot do too much. What I will say, however, is that, having read the latest report by the expert working group, it is clear that there is a concern, highlighted by my right hon. Friend the Member for Hemel Hempstead and others, about the contradiction between what it was asked to do and what it then actually found out. The question is whether there is a causal link or an association. We need to explore that: were the terms of reference of this expert working group followed in the way it carried out its investigation? On that, I absolutely agree: we need to look further into what exactly has been done here.

Further evidence from the expert working group is due to be published in the new year. That will be important.

Hormone Pregnancy Tests

Yasmin Qureshi Excerpts

Thursday 16th November 2017 Commons Chamber

[Yasmin Qureshi (Bolton South East) (Lab)]

(Urgent Question): To ask the Secretary of State for Health to make a statement on the recently published “Report of the Commission on Human Medicines’ Expert Working Group on Hormone Pregnancy Tests”.

[The Parliamentary Under-Secretary of State for Health (Steve Brine)]

Yesterday, the Commission on Human Medicines published the report of its expert working group on hormone pregnancy tests. As I said at Health questions on Tuesday, this subject demands the utmost sensitivity and I will do my best.

Based on its extensive and thorough review, the group’s overall finding, endorsed by the Commission on Human Medicines, is that the available scientific evidence, taking all aspects into consideration, does not support a casual association between the use of hormone pregnancy tests, such as Primodos during early pregnancy, and adverse outcomes of pregnancy with regard to either miscarriage, stillbirth or congenital abnormalities. Ministers have accepted the advice of the Commission on Human Medicines. A written ministerial statement was published yesterday, along with a copy of the report.

In the UK, hormone pregnancy tests first became available for diagnosing pregnancy in the 1950s. Between then and 1978, when Primodos was withdrawn from the market in the UK, a number of studies that investigated a possible link between women being given a hormone pregnancy test to diagnose pregnancy and the occurrence of a range of congenital anomalies in their babies was published. Although there was never any reliable evidence that HPTs were unsafe, concern about the issue, coupled with the development of better pregnancy tests, meant that a number of precautionary actions were taken to restrict the use of HPTs. The tests were voluntarily removed from the market by the manufacturers.

The body of information subsequently accrued by the Association for Children Damaged by Hormone Pregnancy Tests and other campaigners led to a parliamentary debate in 2014, I think in Westminster Hall, during which the then Minister for life sciences, my hon. Friend the Member for Mid Norfolk (George Freeman), stated that he would instruct that all relevant documents held by the Department of Health be released. In addition, he determined that an independent review of the papers and all the available evidence was justified. The purpose of the review was to ascertain whether the totality of the available data, on balance, supported a casual association between use of a hormone pregnancy test by the mother and adverse pregnancy outcomes. It also considered whether, alternatively, the anomalies could have been due to chance alone, or other factors.

The final report summarises the scientific evidence that was considered by the expert working group, its conclusions on the evidence, and its recommendations. All the available relevant evidence on a possible association has been extensively and thoroughly reviewed with the benefit of up-to-date knowledge by experts from the relevant specialisms. The evidence reviewed by the expert working group will be published in the new year, once it has been rightly checked in line with the legal duties of data protection and confidentiality.

In addition to the overall conclusion, the expert working group has made a number of recommendations to safeguard future generations through strengthening the systems in place for detecting, evaluating, managing and communicating safety concerns about the use of medicines in early pregnancy. I recognise that the conclusion of the report will be a disappointment to some, but I hope that they will see the recommendations as positive. They are a credit to the efforts of the Association for Children Damaged by Hormone Pregnancy Tests and the all-party group on oral hormone pregnancy tests, which is chaired by the hon. Lady, and also a lasting legacy.

[Yasmin Qureshi]

I am so disappointed with the Minister’s response. Clearly he is just reading what his staff and the Department have been telling him. I wish the Minister would actually go through the documents submitted to the inquiry and those documents that we had, because if he had read them, he would never have to come the Dispatch Box and said what he has said.

You will be aware, Mr Speaker, that I have raised this issue in Parliament on a number of occasions. In 2014, an expert working group was set up to look at a possible association—not a casual link or a causal link. I am sure that hon. Members agree that that means that a lesser burden of proof is required. The first thing that the commission did was to say that it had found no causal connection, but it was never asked to do that—it was asked to look for a possible association. In 2014, the then Minister made promises about statutory oversight. From the papers we had, there appeared to be a clear criminal responsibility regarding the statutory body, the Committee on the Safety of Medicines, and the people who ran it, given that so much evidence was adduced to them. They were alerted to the fact that Primodos was causing deformities and miscarriages in women, but they totally ignored that evidence. In fact, the person in charge actually said that he wanted to cover it up so that nobody could be sued. It is therefore highly surprising that the commission has come up with this recommendation.

The commission was shown evidence from many studies, the majority of which showed conclusively that when the drug was given to rabbits and rats—mammals, like ourselves—the tissues were damaged. There were—

[Mr Speaker]

Order. I am grateful to the hon. Lady, but I am afraid, although she is highlighting an immensely important matter, and one that she has highlighted before, she has not asked a question—[Interruption.] Order. She has reached her limit and that is it. I have told her, as I have other Members. I have lost count of the number of times Members have been told that if they have an urgent question, they can begin with a few observations—a sentence or two—in response to the Minister, and then questions must follow, but that is not what has happened. I have the highest respect for the hon. Gentleman’s knowledge of and commitment to this subject, but she cannot speak for two minutes and then indicate, “I’m about to get to my questions.” Sorry, I say to her—[Interruption.] Order. No, sorry, but you have had your time. It is up to Members to stick to the limits, so other colleagues will now have to pursue this matter. I genuinely thank her for what she has said, but Members really must observe procedures. If I may say so, there has never been a more enthusiastic friend of the House than me in the granting of urgent questions, but Members must then follow the procedure. That is the situation. I call Anna Soubry.